WuXi XDC Cayman Inc. is a leading global CRDMO focused on antibody drug conjugates (ADC) and the broader bioconjugate market. It provides end-to-end contract research, development and manufacturing services for bioconjugates, including ADCs. Its services cover antibody intermediates and other biologics intermediates, chemical payloads and linkers, as well as bioconjugate drug substances and drug products. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. As of December 2023, 143 on-going integrated projects are under development at WuXi XDC, including 59 post-IND bioconjugate projects, among which 21 projects are in phase II/III.
Our XDC Analytical Sciences Department (XAS) now has open positions for Principal Scientist and Assistant Director for physicochemical analysis. We sincerely look forward to enthusiastic candidates willing to engage in ADC or bioconjugate analysis.
Responsibilities:
1. Lead the analytical activities in CMC projects as function leader or function sponsor of Analytical Sciences. Coordinate with internal experts and other CMC functional areas to design tailored studies to meet regulatory standards and project objectives. Closely monitor the project with continuous scientific and technical support. Proactively identify potential issues and provide constructive suggestions timely. Prepare the analytical sections of filing dossiers to support regulatory submission including INDs and BLAs.
2. Engage directly with domestic and international clients to convey analytical progress and resolve project-related technical challenges.
3. Cultivate talent and foster continuous improvements in physicochemical analysis and project management practices.
4. Laboratory management, including compliance, EHS, 5S, and instrumentation.
Qualifications:
1. Ph.D. or M.S. in biochemistry, protein science, analytical chemistry, or related discipline, with specialized training in HPLC/UPLC, CE/iCIEF, or MS techniques.
2. Proficient understanding of HPLC/CE/MS principles and technologies, and hands-on experience in operation, maintenance and troubleshooting of HPLC/CE/MS.
3. Demonstrated expertise in physicochemical analysis of proteins and bioconjugates.
4. Working experience as function leader or function sponsor for CMC projects.
5. Strong team player with exceptional interpersonal, communication and presentation abilities, both written and verbal.
6. Proven track record as a proactive, independent researcher with advanced problem-solving skills and multitasking abilities.
7. Proficient in English communication, including reading, listening, writing, and speaking.
Personal Growth/Career Development
1. Embrace a multi-level, diversified talent training and development system of WuXi XDC, comprehensively developing general skills, technical capabilities and leadership.
2. Gain extensive technical experience for biopharmaceutical analysis through WuXi XDC’ global technology platform.
3. Accumulate abundant CMC project experiences in a few years, not only in bioconjugates analysis, but also in process development, manufacturing and regulation submissions.
4. Have chance to learn, work and grow with WuXi XDC in long-term development.